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FDA Bucks White House, Issues Strict Vaccine Guidance

White House

(Jonathan Cutrer, Flickr)

7 Oct. 2020. The U.S. Food and Drug Administration yesterday issued guidance for Covid-19 vaccine developers, requiring extended follow-up with clinical trial participants. The requirement for an emergency authorization to test vaccines among participants for two months after receiving a vaccine or placebo in late-stage clinical trials will prevent vaccine sponsors from reporting their results before the U.S. election day on 3 November, despite public pressure from President Trump and his aides for quicker reporting.

FDA quietly announced publication of its guidelines for an emergency use authorization, or EUA, yesterday in a one-line item as part of the agency’s daily wrap-up of Covid-19 developments. Regulatory guidance reflects the agency’s current thinking an expectations for drugs and biologics, offering developers of Covid-19 vaccines in this case, an outline and key factors FDA intends to use to review these products.

An EUA allows FDA to temporarily authorize unapproved drugs, biologics, or diagnostics under emergency conditions. EUA requirements are less stringent than full licensing, but still require data from clinical trials showing that the product can treat or prevent the condition, and its benefits largely outweigh the risks. For Covid-19, a medical state of emergency has been in effect since 27 March.

FDA’s guidance repeatedly highlights that vaccines to prevent Covid-19 will be given to millions of healthy people, thus even for an EUA, the agency is requiring developers to meet strict standards for testing, manufacturing, and distribution. FDA is asking developers to show at least 50 percent fewer vaccine recipients in late-stage clinical trials get infected than placebo recipients, with a low-end confidence interval not falling beneath 30 percent.

The guidance specifically calls for a median follow-up period for participants in late-stage trials of at least two months after completion of the full vaccine regimen, in most cases two doses about four weeks apart. FDA says this period is needed to adequately assess a vaccines benefit/risk profile, including adverse effects and immune system responses. In addition, developers need to provide detailed safety data from large numbers of trial participants for local and systemic adverse effects, risk of contracting respiratory diseases from the vaccine, and tracking of adverse effects among participants for at least one month following the vaccine regimen.

Top White House officials, including Donald Trump, made it clear for some time that they want FDA to announce a vaccine for Covid-19 before election day. The New York Times reported on Monday that FDA submitted its Covid-19 vaccine guidance two weeks earlier, where it languished in review by the Office of Management and Budget that clears all new regulations. In addition, objections from President Trump’s chief of staff Mark Meadows held-up clearance of the document.

But the Times also reported that FDA circulated the draft guidance to its Vaccines and Related Biological Products Advisory Committee, or VRBPAC, a standing group that plans to meet before any EUA for Covid-19 vaccines is granted, as well as vaccine developers. By FDA going public with the guidance, and with broad support from industry for careful review of Covid-19 vaccines — see our story on 8 September — Office of Management and Budget finally cleared the guidance document yesterday.

Last night, Donald Trump continued to express his displeasure on Twitter, tagging FDA commissioner Stephen Hahn.

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